MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	11609481
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the tubing caused an air in line alarm on the pump from a hole that was noted in the pump segment which leaked.There was no report of harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing caused an air in line alarm on the pump from a hole that was noted in the pump segment which leaked was confirmed.During functional testing the set leaked from a small hole at the top of the silicone segment.Magnified inspection identified a small hole on the silicone segment.No tool marks or crush marks were observed on the upper fitment near the small hole.The root cause of the hole damage could not be definitively determined.
Event or Problem Description
The customer reported that the tubing caused an air in line alarm on the pump from a hole that was noted in the pump segment which leaked.There was no report of harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8265758
• Report Number: 9616066-2019-00164
• Device Sequence Number: 1318735
• Product Code: FPA
• UDI-Device Identifier: 10885403232596
• UDI-Public: 10885403232596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11609481
• Device Catalogue Number: 11609481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015, TD (B)(6) 2018; 8100,8015, TD (B)(6) 2018
• Patient Age: 4 DA
• Patient Weight: 3